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Study of Patient Use and Perception of the Travatan Dosing Aid

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fully functional monitoring device
Partially functional monitoring device
Non-functional monitoring device
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Travatan Dosing Aid, compliance monitoring dispenser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Open angle glaucoma or ocular hypertension
  • Presently using Travatan eye drops

Exclusion Criteria:

  • Allergy to prostaglandin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    1 Fully functional monitoring device

    2 Partially functional monitoring device

    3 Non-functional monitoring device

    Arm Description

    Fully functional monitoring device

    Partially functional monitoring device

    Non-functional monitoring device

    Outcomes

    Primary Outcome Measures

    Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser

    Secondary Outcome Measures

    Pilot study of the impact of physician monitoring of compliance on patient compliance

    Full Information

    First Posted
    January 22, 2008
    Last Updated
    November 8, 2016
    Sponsor
    Wills Eye
    Collaborators
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00626067
    Brief Title
    Study of Patient Use and Perception of the Travatan Dosing Aid
    Official Title
    Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wills Eye
    Collaborators
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.
    Detailed Description
    Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio): Fully functional Travatan compliance monitor Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact Travatan compliance monitor with LCD display, alarms and compliance monitor disabled. At end of study, patients fill out questionnaire assessing Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc patient's belief as to whether their compliance was monitored or not Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored. The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma
    Keywords
    Travatan Dosing Aid, compliance monitoring dispenser

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 Fully functional monitoring device
    Arm Type
    Active Comparator
    Arm Description
    Fully functional monitoring device
    Arm Title
    2 Partially functional monitoring device
    Arm Type
    Active Comparator
    Arm Description
    Partially functional monitoring device
    Arm Title
    3 Non-functional monitoring device
    Arm Type
    Sham Comparator
    Arm Description
    Non-functional monitoring device
    Intervention Type
    Device
    Intervention Name(s)
    Fully functional monitoring device
    Intervention Description
    Pt received fully functional monitoring dispenser for use with their Travatan eye drops
    Intervention Type
    Device
    Intervention Name(s)
    Partially functional monitoring device
    Intervention Description
    Patient received a particually functional Travatan Compliance Monitoring Dispenser
    Intervention Type
    Device
    Intervention Name(s)
    Non-functional monitoring device
    Intervention Description
    Patient received a non functioning Travatan Compliance Monitoring Dispenser
    Primary Outcome Measure Information:
    Title
    Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Pilot study of the impact of physician monitoring of compliance on patient compliance
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Open angle glaucoma or ocular hypertension Presently using Travatan eye drops Exclusion Criteria: Allergy to prostaglandin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonathan S. Myers, MD
    Organizational Affiliation
    Wills Eye Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    A Manuscript has been accepted and published in Patient Preference and Adherence.
    Links:
    URL
    https://doi.org/10.2147/PPA.S114746
    Description
    Patient Preference and Adherence

    Learn more about this trial

    Study of Patient Use and Perception of the Travatan Dosing Aid

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